A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery

NCT01355926 | Completed

• 1 other identifier: 11-034
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to help us to better understand the effects of two different types of surgical techniques on pain and quality of life in patients with precancerous lesions or early stage mouth cancers.

Conditions

Head and Neck Cancer

Keywords

Flexible Fiber-based CO2 Laser; Monopolar Cautery; Oral Cavity Lesions; Quality of life; Assessing Pain; 11-034

Outcome Measures

Primary Outcomes (1)

• To demonstrate that for treatment of oral benign, oral leukoplakia and superficial T1N0M0 oral cavity lesions, CO2-fiber based resection generates less thermal damage compared to monopolar cautery

  Leading to improved patient quality of life and post-operative recovery as manifested by reduced post-operative pain. Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale.

  1 month

Secondary Outcomes (1)

• to evaluate differences between the two surgical modalities

  1 month

Study Arms (2)

Flexible Fiber-based CO2 Laser

EXPERIMENTAL

In the CO2 excised group, the resection will be performed at 15W, at a distance of 1cm from the tissue. Here too, if required, the bipolar will be used to achieve hemostasis The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Other: Flexible Fiber-based CO2 Laser, Quality of Life forms

electrocautery resection

EXPERIMENTAL

In the electrocautery excised group, the cut and coagulation modes used will be each at 25 Malis power setting. First, cut mode will be used to mark out the lesion. Subsequently, coagulation mode will be used for excision. Bipolar cautery will then be used at 25 Malis for hemostasis. The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Other: electrocautery resection and quality of life forms

Interventions

Flexible Fiber-based CO2 Laser, Quality of Life forms OTHER

. Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Flexible Fiber-based CO2 Laser

electrocautery resection and quality of life forms OTHER

Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

electrocautery resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven diagnosis or clinical diagnosis of any benign oral cavity lesion. Pre-surgical biopsy will not be required if lesion is suspected to be benign.
• Biopsy proven diagnosis or clinical diagnosis of premalignant oral cavity lesions (leukoplakia, erythroplakia, lichen planus, dysplasia)Pre-surgical biopsy will not be required if lesion is suspected to be benign.
• Biopsy proven diagnosis of small superficial oral cavity SCC (stage T1N0) requiring resection without the need for neck dissection.
• All pathology will be reviewed at MSK to confirm diagnosis.
• The lesion plus the resection margin should not exceed 4.0 cm circumferentially.
• Planned to undergo surgical treatment by resection without flap reconstruction and without neck dissection.
• All patients age 18 years of age and older.
• Karnofsky performance score over 60.
• Patients on blood thinners (aspirin or Coumadin) will be asked to stop medications 7 days prior to surgery. In the case of Coumadin, patients are switched to lovenox 7 days prior to surgery and this is stopped the day before surgery. Following surgery aspirin or Coumadin are recommenced 48 hours postop.

You may not qualify if:

• Patients with previous Head and Neck radiation
• Pregnant or lactating female patients.
• Patients with oral cavity squamous cell cancer requiring neck dissection

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• OMNIGUIDE: collaborator

Study Sites (4)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memoral Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Ian Ganly, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: May 1, 2011
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

US (4)